Presentation Title: Comparison of Regulatory System between US and China

Contents:

The speech is mainly to outline the key changes before and after the reform of the Chinese regulatory system, and to compare the current regimes with the United States. The presentation will present an outlook of the possible changes in China in the future. The focus of the speech is on how the US and Chinese companies should leverage these changes to accelerate and improve the success rate of innovative drug development.

Before founding FMD in 2007, Dr. Zhang was the Head of Clinical Development and Head of Safety Assessment at Sigma-Tau Research Inc., a leading Italian Pharmaceutical Company. Prior to that,He was the Vice President at the Quintiles Transnational Corp., the world largest clinical CRO, and Chairman of Quintiles Medical Development (Shanghai) Company Ltd.,

Dr. Zhang is a member of grant review committee for National Drug Development Fund of China, and is also a consultant for the China Food and Drug Administration (CFDA, now called CNDA). He is a member of ICH E19 Expert Working Group. He is also chairing the committee of Pharmaceutical R&D, China Pharmaceutical Industry Research and Development Association. Dr. Zhang is also a senior consultant for the Chinese Academy of Medical Sciences and Peking Union Medical College. He was a member of the Overseas Expert Committee on New Drug R&D for the Ministry of Science and Technology of China, and was the secretary-general of the Association of “Thousand Talent” Expert from 2011-2017. Dr. Zhang was the former board of directors for the Sino-American Pharmaceutical Association (SAPA) and was the former president of Chinese Biopharmaceutical Association-USA (CBA). Dr. Zhang is chairing the government relationship committee of Bayhelix - an organization whose members are senior executives from life-science organizations in USA and China.

Dr. Zhang received his pre-med training from Peking University and received M.D. from Peking Union Medical College. He then went to the Harvard School of Public Health and received MPH in health policy and management. Then he went to the Wharton Business School of the University of Pennsylvania, where he obtained his master’s degree in healthcare management in 1998.